The FDA has classified St. Jude Medical's ($STJ) voluntary medical device advisory letter to physicians from Nov. 28 relating to its Riata and Riata ST silicone defibrillation leads as a Class I recall, putting it in the most serious category.
The FDA decided to designate it a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.
News of the classification comes weeks after St. Jude advised doctors that its Riata leads, which connect implanted defibrillators to the heart, have a higher rate of insulation failures than initially reported. In a letter posted to its website, the company noted that of the more than 227,000 Riata and Riata ST silicone leads sold worldwide over the past 9 years, the incidence rate is estimated to be 0.63%, not the 0.47% communicated in December 2010, when the company stopped selling the product.
Although the recall falls in the most serious category, a St. Jude spokeswoman said the designation has no practical effect because Riata is no longer on the market, according to the Minneapolis Star-Tribune. That said, about 79,000 Riata and Riata ST leads remain implanted in patients in the U.S., the company said in a release.
"At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads," said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society president and a member of St. Jude Medical's medical advisory board, in a release.
- see the St. Jude release
- check out the Star-Tribune's take
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